Evaluation of Efficacy and Safety of Symbicort as an Add-on Treatment to Spiriva in Patients With Severe COPD.

Condition(s) targeted: Chronic Obstructive Pulmonary Disease, COPD

Intervention: Symbicort (budesonide/formoterol turbuhaler 320/9ug) (Drug); Spiriva (tiotropium bromide 18ug) (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Tomas Andersson, MD, Study Director, Affiliation: AstraZeneca R&D Lund
Tobias Welte, MD, Principal Investigator, Affiliation: Hannover Medical School

The purpose of this study is to investigate the effect of combined treatment with Symbicort and Spiriva, in terms of improvement of lung function, symptoms and inflammatory markers, in patients with severe COPD.

Official title: A 12-Week, Double-Blind, Randomised, Parallel Group, Multi-Centre, Study to Evaluate Efficacy and Safety of Budesonide/Formoterol (Symbicort Turbuhaler) 320/9 µg One Inhalation Twice Daily on Top of Tiotropium (Spiriva) 18 µg One Inhalation Once Daily

Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study

Primary outcome: The primary outcome variable will be pre-dose FEV1 assessed by spirometry at clinic visits.

Secondary outcome: Secondary outcome variables will be pre-dose and post-dose spirometry measurements at clinic visits, symptoms and health status captured by questionnaires, and reliever medication use and Peak Expiratory Flow recorded in daily diary.

Minimum age: 40 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- >=40 years of age, diagnosed COPD with symptoms >=2 years, pre-bronchodilatory FEV1

<=50% of PN

Exclusion Criteria:

- Current respiratory tract disorder other than COPD, history of asthma or rhinitis,

significant or unstable cardiovascular disorder

Research Site, QUEBEC, Canada

Research Site, CHAMALIERES, France

Research Site, CREIL, France

Research Site, FEROLLES ATTILLY, France

Research Site, GRASSE, France

Research Site, LILLE, France

Research Site, MARSEILLE CEDEX 06, France

Research Site, METZ, France

Research Site, MONTPELLIER, France

Research Site, PERPIGNAN, France

Research Site, POITIERS CEDEX, France

Research Site, SELESTAT, France

Research Site, ST LAURENT DU VAR, France

Research Site, STRASBOURG CEDEX, France

Research Site, TOULOUSE CEDEX 9, France

Research Site, BERLIN, Germany

Research Site, GELSENKIRCHEN, Germany

Research Site, HAGEN, Germany

Research Site, HANNOVER, Germany

Research Site, KASSEL, Germany

Research Site, KOBLENZ, Germany

Research Site, LEIPZIG, Germany

Research Site, MARBURG, Germany

Research Site, POTSDAM, Germany

Research Site, ASZ�D, Hungary

Research Site, BAJA, Hungary

Research Site, BALASSAGYARMAT, Hungary

Research Site, BUDAPEST, Hungary

Research Site, CEGL�D, Hungary

Research Site, DEBRECEN, Hungary

Research Site, F�ZESABONY, Hungary

Research Site, J�SZBER�NY, Hungary

Research Site, KOML�, Hungary

Research Site, NY�REGYH�ZA, Hungary

Research Site, T�R�KB�LINT, Hungary

Research Site, V�S�ROSNAM�NY, Hungary

Research Site, BYDGOSZCZ, Poland

Research Site, CHRZAN�W, Poland

Research Site, I�AWA, Poland

Research Site, KRAK�W, Poland

Research Site, �OM�A, Poland

Research Site, PIEKARY �L�SKIE, Poland

Research Site, TARN�W, Poland

Research Site, TUREK, Poland

Research Site, ZAWADZKIE, Poland

Research Site, KO�ICE, Slovakia

Research Site, LIPTOVSKY HRADOK, Slovakia

Research Site, LUCENEC, Slovakia

Research Site, NOVE MESTO NAD VAHOM, Slovakia

Research Site, NOVE ZAMKY, Slovakia

Research Site, PIESTANY, Slovakia

Research Site, POPRAD, Slovakia

Research Site, POVAZSKA BYSTRICA, Slovakia

Research Site, PRESOV, Slovakia

Research Site, PRIEVIDZA, Slovakia

Research Site, REVUCA, Slovakia

Research Site, TRNAVA, Slovakia

Research Site, ZILINA, Slovakia

Research Site, �TVIDABERG, Sweden

Research Site, H�LLVIKEN, Sweden

Research Site, LIMHAMN, Sweden

Research Site, LUND, Sweden

Research Site, MALM�, Sweden

Research Site, MOTALA, Sweden

Research Site, STOCKHOLM, Sweden

Research Site, UPPSALA, Sweden

Research Site, CALGARY, Alberta, Canada

Research Site, VANCOUVER, British Columbia, Canada

Research Site, BARCELONA, CATALU�a, Spain

Research Site, REUS (TARRAGONA), CATALU�a, Spain

Research Site, MADRID, Comunidad De Madrid, Spain

Research Site, REQUENA (VALENCIA), Comunidad Valenciana, Spain

Research Site, VALENCIA, Comunidad Valenciana, Spain

Research Site, PONTEVEDRA, GALICIA, Spain

Research Site, WINNIPEG, Manitoba, Canada

Research Site, CONCORD, New South Wales, Australia

Research Site, SYDNEY, New South Wales, Australia

Research Site, ST. JOHN'S, Newfoundland and Labrador, Canada

Research Site, HALIFAX, Nova Scotia, Canada

Research Site, LINDESBERG, OREBRO LAN, Sweden

Research Site, MISSISSAUGA, Ontario, Canada

Research Site, TORONTO, Ontario, Canada

Research Site, LA MALBAIE, Quebec, Canada

Research Site, TROIS-RIVI�RES, Quebec, Canada

Research Site, AUCHENFLOWER, Queensland, Australia

Research Site, CARINA HEIGHTS, Queensland, Australia

Research Site, NORTH MACKAY, Queensland, Australia

Research Site, SASKATOON, Saskatchewan, Canada

Research Site, ADELAIDE, South Australia, Australia

Research Site, DAW PARK, South Australia, Australia

Research Site, CLAYTON, Victoria, Australia

Research Site, MALVERN, Victoria, Australia

Research Site, NEDLANDS, Western Australia, Australia

Starting date: May 2007
Last updated: March 28, 2008